QA Associate Scientist

A Biotechnology Company is seeking a QA Associate Scientist in Princeton, NJ.

Role Description

The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the BMS Jump site, including the document change control process, issuance and reconciliation of batch records, batch related forms, product labels, and management of archival and retention of GMP records.

Skills & Requirements

• Minimum of 1 year of relevant document control management experience in a cGMP/FDA regulated environment

• Strong communication and customer service skills.

• Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles

• Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)

• Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement

• Able to prioritize, manage time well, multi-task, and troubleshoot effectively

• Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables

• Possess project management skills.

• Experience interacting with FDA or other regulatory agencies strongly preferred

• Strong knowledge of cGMPs and domestic regulatory requirements

• Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)

• Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network

• Some labeling experience strongly preferred